Company Announcements

Only MCED test on-market to analyze multiple biomarker classes, enhancing early cancer detection

Offered as a laboratory-developed test at $689

Nationwide access enabled through Quest Diagnostics' 7,000 patient access sites

MADISON, Wis.--(BUSINESS WIRE)--Sep. 10, 2025-- Exact Sciences Corp. (Nasdaq: EXAS), a leader in cancer diagnostics, today announced the launch of the Cancerguard™ test, a new multi-cancer early detection (MCED) blood test that is now available as a laboratory-developed test (LDT) in the United States. Cancerguard is the first MCED test commercially available that analyzes multiple biomarker classes to help detect a wide range of cancers, including those that often go undiagnosed until later stages when treatment options are limited.

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The Cancerguard test kit

Nearly 70 percent of annual cancer cases and deaths in the U.S. occur in cancers with no recommended screening.^1,2,3 The Cancerguard test can help address the unmet need by complementing existing routine screening and extending the reach of early detection. With a simple blood draw, the Cancerguard test can detect signals from cancer types responsible for more than 80 percent of annual U.S. cancer diagnoses, including some with the highest mortality rates, such as pancreatic, ovarian, liver, esophageal, lung, and stomach cancers.^1,4 Overall, the Cancerguard test can detect more than 50 cancer types and subtypes.⁵

The Cancerguard test delivered 68 percent sensitivity across six of the deadliest cancers and 64 percent overall sensitivity across a broader range of cancers, excluding breast and prostate, in test-development studies. It also found more than a third of stage I or II cancers, demonstrating its ability to detect disease when it’s most treatable.^1,2,4* Additionally, the test achieved high specificity of 97.4 percent, helping to minimize false positives and avoid unnecessary procedures.⁴ Modeling shows that over a 10-year period, use of Exact Sciences’ MCED technology alongside current screening methods could reduce stage IV cancer diagnoses by 42 percent and lower overall cancer-related mortality by 18 percent.⁶ Together, these findings underscore the Cancerguard test’s potential to meaningfully improve outcomes and elevate the standard of cancer detection.

The Cancerguard test will be delivered through Exact Sciences’ expansive commercial and operational infrastructure, including a national sales force that engages primary care physicians, oncologists, and leading health systems. To support patient access, Exact Sciences has entered into an agreement with Quest Diagnostics to enable blood collection at the company’s approximately 7,000 patient access sites across the U.S., including through its patient service centers and in-office phlebotomists in provider offices, as well as mobile phlebotomy services for at-home collections.

“Cancerguard builds on the legacy of Cologuard, which has delivered more than 20 million test results and transformed colorectal cancer screening,” said Kevin Conroy, chairman and CEO of Exact Sciences. “Backed by strong science and developed to screen for many of the deadliest cancers, the Cancerguard test represents the next bold step in our mission to detect cancer earlier. With deep, trusted relationships across the health care system, Exact Sciences has the reach, credibility, and commitment to bring earlier answers to more people. This is the moment where we begin to change the course of cancer forever and give people power over their futures.”

The Cancerguard test is the culmination of nearly a decade of development and is backed by rigorous science in partnership with top academic institutions. The test is supported by data from robust test-development studies, such as DETECT-A and ASCEND 2, involving more than 20,000 participants, including the first-ever prospective interventional MCED trial.^7,8,9 To further validate clinical utility and support broad adoption, Exact Sciences is actively enrolling up to 25,000 participants in the Falcon registry, a real-world evidence study conducted under a U.S. FDA-reviewed Investigational Device Exemption (IDE).¹⁰ This comprehensive body of evidence is designed to inform future regulatory submissions, support payer discussions on coverage and reimbursement, and guide efforts to include the Cancerguard test in clinical guidelines.

“The Cancerguard test offers a critical early warning that cancer may be present and helps inform an imaging-guided pathway to diagnosis, giving people the chance to act when it matters most,” said Dr. Tom Beer, chief medical officer for multi-cancer early detection at Exact Sciences. “As adoption grows, we’ll look back and ask how we ever settled for screening for only a few cancers while letting the majority go undetected. Like the smartphone redefined communication, Cancerguard has the power to redefine cancer detection and the future of early intervention.”

Exact Sciences delivers the Cancerguard test with comprehensive support for both patients and clinicians. The test integrates seamlessly into existing workflows and electronic medical records (EMRs) and is backed by industry-leading care navigation support, including dedicated support for patients with positive results. The Cancerguard test is recommended for individuals aged 50-84 with no known cancer diagnosis in the past three years and can be considered annually. It is priced at $689 and may be eligible for flexible spending and health savings account use, with payment plans available. Additional financial support includes a patient imaging assistance program** to help reduce the impact of non-covered imaging costs for eligible patients. The Cancerguard test is currently available for providers to order at www.exactsciences.com/cancerguard, with broader consumer telehealth access beginning in October 2025 at www.cancerguard.com.

About Exact Sciences

A leading provider of cancer screening and diagnostic tests, Exact Sciences (Nasdaq: EXAS) helps patients and health care providers make timely, informed decisions before, during, and after a cancer diagnosis. The company’s growing portfolio includes well-established brands such as Cologuard® and Oncotype DX®, along with innovative solutions like the Cancerguard™ test for multi-cancer early detection and the Oncodetect™ test for molecular residual disease and recurrence monitoring. Exact Sciences continues to invest in a robust pipeline of advanced cancer diagnostics aimed at improving outcomes. For more information, visit ExactSciences.com, follow @ExactSciences on X, or connect on LinkedIn and Facebook.

Forward-looking statement

This news release contains forward-looking statements concerning our expectations, anticipations, intentions, beliefs, or strategies regarding the future. These forward-looking statements are based on assumptions that we have made as of the date hereof and are subject to known and unknown risks and uncertainties that could cause actual results, conditions and events to differ materially from those anticipated. Therefore, you should not place undue reliance on forward-looking statements. Examples of forward-looking statements include, among others, statements regarding our expectations for the commercialization of the Cancerguard test, the performance characteristics and health care benefits of the Cancerguard test in a commercial setting, and the potential for guidelines inclusion and insurance reimbursement. Risks and uncertainties that may affect our forward-looking statements are described in the Risk Factors sections of our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q, and in our other reports filed with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

References

1. Siegel RL, Kratzer TB, Giaquinto AN, Sung H, Jemal A. Cancer statistics, 2025. CA Cancer J Clin. 2025;75(1):10-45.
2. United States Preventive Services Task Force. A and B recommendations. Published 2022. Accessed August 1, 2025. https://uspreventiveservicestaskforce.org/uspstf/recommendation-topics/uspstf-and-b-recommendations.
3. Data on file. Calculated cancers without USPSTF recommended screening tests. 2025. Medical Affairs, Exact Sciences, Madison, WI.
4. Cancerguard Clinician Brochure. Exact Sciences Corporation. Madison, WI.
5. Data on file. Cancerguard Cancer Subtype Analysis. [MED-REF-01259]. Exact Sciences. Madison, WI; September 2025
6. Jagpreet Chhatwal, Jade Xiao, Andrew ElHabr, et al. The potential of multi-cancer early detection screening in reducing cancer incidence and mortality in high-risk groups: A modeling study. JCO 43, 10542-10542(2025).
7. Lennon AM, Buchanan AH, Kinde I, et al. Feasibility of blood testing combined with PET-CT to screen for cancer and guide intervention. Science. 2020;369(6499).
8. Douville C, Hogstrom L, Gainullin V, et al. Design and enrollment for a classifier development study for a blood-based multi-cancer early detection (MCED) test. Presented at: ESMO Congress; October 2023; Madrid, Spain. Poster #FPN 189P.
9. Kisiel JB, Ebbert JO, Taylor WR, et al. Shifting the cancer screening paradigm: developing a multi-biomarker class approach to multi-cancer early detection testing. Life (Basel). 2024;14(8):925.
10. FALCON Real World Evidence Registry. Identifier: NCT06589310. https://clinicaltrials.gov/study/NCT06589310. Accessed August 1, 2025.

*Excludes breast and prostate

**Patients must apply. Eligibility depends on program qualifications, is not guaranteed, and is subject to change. The program will not reimburse any covered imaging costs, including copay, coinsurance and/or deductible amounts determined by insurance. For more information or to apply, patients should call 1-844-870-8870.

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Media Contact
Allison Barry
+1 980-297-1957
abarry@exactsciences.com

Investor Contact
Derek Leckow
+1 608-893-0009
investorrelations@exactsciences.com

Source: Exact Sciences Corp.